Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers

The University of Hong Kong (HKU)

Status: Not yet enrolling

Conditions: Cancer Caregivers; Insomnia Chronic

Treatments: Behavioral: Sleep hygiene education; Behavioral: Nurse-Supported Mobile App for Self-Help CBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT07089797

Nurse-supported CBT-I (FULL)

Details and patient eligibility

About

This mixed-methods randomized controlled trial investigates whether a nurse-supported mobile app for self-help cognitive behavioral therapy for insomnia (CBT-I) effectively reduces insomnia severity among informal cancer caregivers, compared to sleep hygiene education.<br><br>

The primary research question is:<br> Does nurse-supported mobile app for self-help CBT-I lower insomnia severity among cancer caregivers compared to sleep hygiene education at post-intervention and 3-month follow-up?<br><br>

A total of 208 participants will:<br>

1. Be randomly assigned to one of two groups:<br> (i) the nurse-supported mobile app-based self-help CBT-I group, which involves a 6-week CBT-I program delivered via a WeChat mini program along with weekly nurse support sessions (up to 20 minutes each); or<br> (ii) the sleep hygiene education group.<br>
2. Complete assessments at baseline, post-intervention, and 3-month follow-up to measure changes in insomnia severity (primary outcome). Secondary outcomes include subjective sleep outcomes, psychological well-being, caregiver burden, fatigue, health-related quality of life, and participants' acceptability and satisfaction.<br><br>

As recommended for trials of complex interventions, investigators will conduct a process evaluation in alignment with the Medical Research Council (MRC) guidance. The key functions of the process evaluation include: *(1) implementation, (2) mechanisms of impact, and (3) context.*

Enrollment: 208 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Informal caregiver (e.g., family member or a friend) who co-resides with a cancer survivor of any site or stage and provides at least 4 hours of unpaid daily care. If two or more caregivers are available for a cancer survivor, the one providing most of the daily care will be included.
• Able to understand the research procedures, and read and communicate in Chinese
• Able to use WeChat
• Insomnia severity index scores > 7

Exclusion criteria

• Another sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome, rapid eye movement behavior disorder), besides insomnia, that is not adequately treated
• Psychotic disorders (e.g., bipolar disorder, schizophrenia); Suicidal ideation with intent and plan OR attempted suicide within the past 2 months
• Currently taking any psychotropic drugs (e.g., antidepressants, anxiolytics, sleep medications)
• Unstable or acute medical condition or condition requiring surgery in the next 6 months; Pregnancy; or Epilepsy
• Currently participating in any other interventional program
• Prior experience with CBT-I
• Night, evening, early morning or rotating shift work
• Currently caring for a cancer patient receiving hospice care

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers

Experimental group

Treatment:

Behavioral: Nurse-Supported Mobile App for Self-Help CBT-I

Sleep hygiene education

Active Comparator group

Treatment:

Behavioral: Sleep hygiene education